The Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices (ACIP) has recommended that adults 60 and older—in consultation with their doctors—receive vaccines to prevent lower respiratory tract disease caused by respiratory syncytial virus (RSV).
The thumbs-up, however, was anything but enthusiastic.
Instead of telling seniors that they should be vaccinated, the panel has said that people may get a dose of GSK’s Arexvy or Pfizer’s Abrysvo if it is right for them.
Both shots were approved by the FDA last month, becoming the industry's first vaccine offerings for RSV, which strikes like a common cold but can progress to severe disease and be fatal, especially for those with underlying conditions.
The death toll from RSV among people 65 and older in the U.S. is between 6,000 and 10,000 per year, according to the CDC.
The panel was hesitant to endorse RSV vaccines for people 65 and older as the vote by ACIP experts was 9-5 to recommend optional use in that population. The experts cited concerns over a lack of adequate enrollment for this age group in clinical trials.
In people ages 60 to 64, the panel was more willing to recommend the vaccines. That vote was 13-0, with one abstention.
The tepid endorsement for the vaccines could hinder sales as the companies prepare to launch their shots this fall. RSV most commonly strikes between December and February.
In the next few days, outgoing CDC Director Rochelle Walensky, M.D., who departs at the end of the month, will decide whether to accept the panel’s recommendations.
The primary sticking point for the committee in assessing the value and safety of the vaccines was that the trials conducted by both companies failed to include enough people of advanced age.
The committee also was disappointed that both companies failed to reveal the price of their vaccines. When pressed, GSK refined its price range, guaranteeing its shot will be available for between $200 and $295 per dose. Pfizer did not move off its price range entering the meeting of between $180 to $270 per shot.
“It is not a guarantee as we are in competitive price negotiations. We have not set a list price,” a Pfizer representative told the committee.
Another concern was the uncertainty of receiving RSV vaccines along with seasonal COVID-19 and flu shots. Since they are all administered in the same general time frame, could their immune responses be compromised? The experts said they would like to see more data on this point.
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